Browse Drug Recalls
1,749 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,749 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,749 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 21, 2016 | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... | Presence of Particulate Matter: identified as cardboard. | Class I | Baxter Healthcare Corp. |
| Jan 21, 2016 | CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose... | Presence of Particulate Matter: identified as dried skin. | Class I | Baxter Healthcare Corp. |
| Jan 15, 2016 | Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manuf... | Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. | Class I | Master Herbs, Inc./Li |
| Jan 9, 2016 | Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed b... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 12... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsul... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsul... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distrib... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distribute... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marke... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 3... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box /... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 4... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / ... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 c... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Mar... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 cap... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules tot... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 4... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 caps... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / ... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 ca... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 c... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 ca... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsul... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsule... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 c... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 5, 2016 | Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T... | Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which ... | Class I | Hospira Inc. |
| Dec 29, 2015 | Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous adm... | Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. | Class I | Complete Pharmacy and Medical Solutions LLC |
| Dec 23, 2015 | Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 23, 2015 | APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclus... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Nuway Distributors, LLC |
| Dec 23, 2015 | Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured f... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 23, 2015 | La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufac... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 15, 2015 | 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx... | Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... | Class I | Baxter Healthcare Corp. |
| Dec 15, 2015 | SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceu... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N O... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu ... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Heal... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Soluti... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E.... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bu... | Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... | Class I | Baxter Healthcare Corp. |
| Dec 15, 2015 | Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 11, 2015 | FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bo... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... | Class I | Reesna, Inc |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.